Double-blind Comparative Study of SYR-472 | NCT01632007

Studies
Double-blind Comparative Study of SYR-472

NCT01632007

Sponsor

Takeda

Status

Completed

Last Update Posted

Dec 11, 2023Actual

Enrollment

245Estimated

Phase

Phase 3

Conditions

Diabetes Mellitus

Interventions

SYR-472
Alogliptin 25 mg
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1128-6104	Registry Identifier	WHO
JapicCTI-121839	Registry Identifier	JapicCTI

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2012Actual

Primary Completion Date

Jul 1, 2013Actual

Completion Date

Jul 1, 2013Actual

First Submitted Date

Jun 27, 2012

First Submission Date that Met QC Criteria

Jun 28, 2012

First Posted Date

Jun 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2023

Last Update Posted Date

Dec 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

245Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
SYR-472 100 mg	Experimental	Drug: SYR-472
Alogliptin 25 mg	Active Comparator	Drug: Alogliptin 25 mg
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SYR-472	Drug		SYR-472 100 mg
Alogliptin 25 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycosylated hemoglobin (HbA1c)	Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).	24 weeks.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant is an outpatient.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Akita	Akita		Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25609193	Derived	Inagaki N, Onouchi H, Maezawa H, Kuroda S, Kaku K. Once-weekly trelagliptin versus daily alogliptin in Japanese patients with type 2 diabetes: a randomised, double-blind, phase 3, non-inferiority study. Lancet Diabetes Endocrinol. 2015 Mar;3(3):191-7. doi: 10.1016/S2213-8587(14)70251-7. Epub 2015 Jan 19.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases